NDC | 55301-406-01 |
Set ID | 34ee7b60-0afc-4607-a78d-0ff3c286b4be |
Category | HUMAN OTC DRUG LABEL |
Packager | Army + Air Force Exchange Service |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- Active Ingredient
- Purpose
-
Uses
- For treatment of cold sores/fever blisters on the face or lips
- Helps relieve the symptoms of itching, burning and pain associated with cold sores/fever blisters in just one day
- Relieves dryness and softens cold sores and fever blisters
- First aid to help protect against infection in minor cuts, scrapes, burns, and sores
-
Warnings
- For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
- Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.
- When using this product avoid contact with eyes. Use only as directed.
- Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.
-
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- Directions
- Other Information
-
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Juice, Arginine, Butylparaben, Camphor, Cetearylisononanoate, Dipropylenglycole Dicaprylate-Dicaprate, Ethylparaben, Eucalyptus Globulus Leaf Oil, Hexyldecanole, Hexyl Decyl Laurate, Menthol,
Methylparaben, Ozokerite, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Poloxamer 407, Propylparaben, Tocopheryl Nicotinate (Vitamin E), Thymol, Zinc Chloride - Questions or Comments?
- PRINCIPAL DISPLAY PANEL
- KEEP OUT OF REACH OF CHILDREN
-
INGREDIENTS AND APPEARANCE
EXCHANGE SELECT COLD SORE TREATMENT
benzalkonium chloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-406 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg in 1 g Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Aloe Vera Leaf (UNII: ZY81Z83H0X) Arginine (UNII: 94ZLA3W45F) Butylparaben (UNII: 3QPI1U3FV8) Camphor (Synthetic) (UNII: 5TJD82A1ET) Cetearyl Isononanoate (UNII: P5O01U99NI) Dipropylene Glycol Caprate/Caprylate Diester (UNII: R6G12EY23X) Ethylparaben (UNII: 14255EXE39) Corymbia Citriodora Leaf Oil (UNII: M63U6N96EB) Hexyldecanol (UNII: 151Z7P1317) Hexyldecyl Laurate (UNII: 0V595C1P6M) Levomenthol (UNII: BZ1R15MTK7) Methylparaben (UNII: A2I8C7HI9T) Ceresin (UNII: Q1LS2UJO3A) Tea Tree Oil (UNII: VIF565UC2G) Poloxamer 407 (UNII: TUF2IVW3M2) Propylparaben (UNII: Z8IX2SC1OH) Alpha-Tocopherol (UNII: H4N855PNZ1) Thymol (UNII: 3J50XA376E) Zinc Chloride (UNII: 86Q357L16B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-406-01 1 in 1 PACKAGE 1 2 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/04/2011 Labeler - Army + Air Force Exchange Service (001695568) Registrant - Ranir LLC (364567615) Establishment Name Address ID/FEI Business Operations Ranir LLC 364567615 label